Prosthetic device for cartilage repair

• US 8,206,457 B2
• Filed: 12/01/2004
• Issued: 06/26/2012
• Est. Priority Date: 12/02/2003
• Status: Expired due to Fees

• Current Assignee: AO Research Institute Davos, Robert Mathys H.C. Dr. Stiftung
• Original Assignee: AO Research Institute Davos, Dr. H. C. Roberts Mathys Stiftung
• Inventors: Luginbuehl, Reto, Richards, Geoff, Gwynn, Lolo Ap
• Primary Examiner(s): Snow, Bruce E
• Assistant Examiner(s): HOBAN, MELISSA A
• Application Number:
  US10/581,270
• Publication Number:
  US 20070282455A1
• Time in Patent Office: 2,764 Days
• Field of Search: 623/23.72, 623/23.51, 623/23.56, 623/23.58
• US Class Current: 623/23.72
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3804 for elbows
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30009 differing in fibre orientations
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30028 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30084 Materials having a crystalline structure
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30205 conical
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30324 differing in thickness
• CPC Class Codes: A61F 2002/30327 differing in diameter
• CPC Class Codes: A61F 2002/30602 : Shaft made of a bundle of anchoring rods or bristles, e.g. fasciculate shaft
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30909 : Nets
• CPC Class Codes: A61F 2002/3092 : having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30925 : etched
• CPC Class Codes: A61F 2002/30929 : having at least two superposed coatings
• CPC Class Codes: A61F 2002/3093 : for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4648 : Means for culturing bone graft
• CPC Class Codes: A61F 2002/4649 : Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0023 : differing in porosity
• CPC Class Codes: A61F 2250/0028 : differing in fibre orientations
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61L 2430/06 : for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges

Abstract

A triphasic prosthetic device for repairing or replacing cartilage or cartilage-like tissue. The prosthetic device comprises a highly oriented hollow body component between a superficial random oriented polymer layer and a base component.

Claims

1. A triphasic prosthetic device for repairing or replacing cartilage or cartilage like-tissue (1) comprising:

a polymeric hollow body component (3) with a number of highly oriented hollow bodies;

a base component (4) comprising a bone substitute material that is a synthetic ceramic to anchor said polymeric hollow body component (3) in or onto an osteochondral environment; and

at least one superficial layer comprising randomly oriented fibres (2) provided on said polymeric hollow body component (3)

wherein more than 50% of said number of highly oriented hollow bodies of the polymeric hollow body component (3) are aligned essentially parallel to the insertion axis of the prosthetic device (1).

2. The device according to claim 1, wherein more then 90% of said hollow bodies are aligned perpendicular to the plane of the articulating surface.

3. The device according to claim 1, wherein an inner channel diameter of the hollow bodies of polymeric hollow body component (3) is in a range of 500 nm to 500 μ

m.

4. The device according to claim 3, wherein the inner channels have a wall thickness ranging between 1 nm and 500 μ

m.

5. The device according to claim 4, wherein the wall thickness is between 100 nm and 250 μ

m.

6. The device according to claim 3, wherein said inner channel diameter is in a range of 5 μ

m to 150 μ

m.

7. The device according to claim 1, wherein the polymeric hollow body component (3) is formed by an assembly of oriented tubes.

8. The device according to claim 7, wherein a space between the assembled tubes is empty or filled with a substance selected from the group consisting of synthetic polymers, natural polymers, biologically engineered polymers, molecules thereof, biomacromolecules and any combination thereof.

9. The device according to claim 1, wherein the hollow body component is a solid block of polymer with channels.

10. The device according to claim 9, wherein the channels are formed by at least one of mechanical, physical and chemical methods in a solid polymer.

11. The device according to claim 10, wherein said solid polymer is porous.

12. The device according to claim 1, wherein lateral distribution of the hollow bodies of component (3) is homogenous, random or in a specific pattern.

13. The device according to claim 1, wherein said hollow bodies of the hollow body component (3) have a height of 50 μ

m to 10 mm.

14. The device according to claim 13, wherein the height is between 100 μ

m and 2 mm.

15. The device according to claim 1, wherein said synthetic ceramic comprises at least one of calcium phosphate, calcium sulfate and calcium carbonate.

16. The device according to claim 15, wherein said calcium phosphate is selected from the group consisting of dicalcium phosphate dihydrate (CaHPO₄x2H₂O), dicalcium phosphate (CaHPO₄), alpha-tricalcium phosphate (alpha-Ca₃(PO₄)₂), beta-tricalcium phosphate (beta-Ca₃(PO₄)₂), calcium deficient hydroxyl apatite (Ca₉(PO₄)₅(HPO₄)OH), hydroxyl apatite (Ca₉(PO₄)₆OH₂), carbonated apatite (Ca₁₀(PO₄)₃(CO₃)₃)(OH)₂) fluoroapatite (Ca₁₀(PO₄)₆(F,OH)₂) chloroapatite (Ca₁₀(PO₄)₆ (Cl, OH)₂), whitlockite ((Ca,Mg)₃(PO₄)₂), tetracalcium phosphate (Ca₄(PO₄)₂O), oxyapatite (Ca₁₀(PO₄)₆O), beta-calcium pyrophosphate (beta-Ca₂(P₂O₇), alpha-calcium pyrophosphate, gamma-calcium pyrophosphate, octacalcium phosphate (Ca₈H₂(PO₄)₆x5H₂O) and mixtures thereof.

17. The device according to claim 1, wherein said synthetic ceramic comprises at least one of metallic, semimetallic components and non-metallic components, preferably magnesium, silicon, sodium, potassium, strontium and lithium.

18. The device according to claim 1, wherein the material is a composite material comprising at least two different components.

19. The device according to claim 1, wherein more than 95% of said hollow bodies are aligned perpendicular to the plane of the articulating surface.

20. The device according to claim 1, wherein the shape of the base component (4) is round cylindrical or conical.

21. The device according to claim 20, wherein the diameter of the base component (4) ranges between 4 and 20 mm, with a height being 1 to 30 mm.

22. The device according to claim 21, wherein the diameter of the base component (4) ranges between 4 and 20 mm, with a height being between 1 to 10 mm.

23. The device according to claim 22, wherein said superficial layer (2) is missing, or formed by uppermost end of the hollow body component.

24. The device according to claim 1, wherein said superficial layer (2) has a thickness of 1 nm to 5 mm.

25. The device according to claim 24, wherein said thickness is in the range of 10 μ

m to 2 mm.

26. The device according to claim 1, wherein at least one of the randomly oriented fibers (2), the polymeric hollow body component (3) and the base component (4) has a liquid absorbing capacity in a range of 0.1% to 99.9%.

27. The device according to claim 26, wherein said liquid absorbing capacity is in a range of 20.0 to 95.0%.

28. The device according to claim 26, wherein the liquid is at least one of an aqueous media and a body fluid.

29. The device according to claim 1, wherein the polymeric hollow body component is cross-linked.

30. The device according to claim 1, further comprising at least one externally added component.

31. The device according to claim 30, wherein said externally added components are cells of different origin.

32. The device according to claim 31, wherein said cells are at least one of autologous cells, allogenous cells, xenogenous cells, transfected cells and genetically engineered cells.

33. The device according to claim 30, wherein chondrocytes, chondral progenitor cells, pluripotent cells, tutipotent cells or combinations thereof are present throughout at least one of the randomly oriented fibers (2) and the polymeric hollow body component (3).

34. The device according to claim 30, wherein osteoplasts, osteo-progenitor cells, pluripotent stem cells, tutipotent stem cells or combinations thereof are present throughout the base component (4).

35. The device according to claim 30, wherein blood or any fraction thereof is present throughout the base component (4).

36. The device according to claim 30, wherein pharmaceutical compounds are contained.

37. A device according to claim 1, wherein a cell barrier layer is additionally provided between said polymeric hollow body component (3) and said base component (4).

38. A device according to claim 37, wherein the cell barrier layer is a cell selective barrier layer.

39. A use of the device according to claim 1 for implantation in articulating joints in humans and animals.

40. The use according to claim 39 for regeneration of articulator cartilagenous tissue.